Digital Fluorography X-Ray System
510(k) K840191
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840191 | Date16 Mar 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a System, X-Ray, Fluoroscopic, Image-Intensified, as classified by regulatory authorities. It employs digital fluorography to capture real-time moving images of internal body structures using X-ray technology, enhancing diagnostic visualization for radiologic procedures. The system leverages an image-intensifier to amplify low-light X-ray images, improving clarity and detail for medical assessment.
The Digital Fluorography X-Ray System is designed for use in radiology departments, where it supports fluoroscopic imaging for procedures such as angiography, contrast studies, and interventional radiology. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate imaging performance. Authorized under FDA 510(k) clearance (K840191) with a classification of Class II, the system adheres to regulatory standards for X-ray equipment, including compliance with 21 CFR 892.1650. No specific sterility or single-use designation is indicated in the data.
Other devices from Adac Laboratories
Questions
AI-generated answers, 20 Sep 2026
What types of medical procedures is this digital fluorography X-ray system primarily used for?
This system is designed for fluoroscopic imaging in radiology departments, supporting procedures like angiography, contrast studies, and interventional radiology. The image-intensifier technology enhances real-time visualization of internal structures, making it ideal for guiding interventions and assessing dynamic processes during these procedures.
Is this device single-use or reusable, and what maintenance does it require?
The Digital Fluorography X-Ray System is a reusable medical device. Since it is not designated as single-use, it requires regular maintenance and calibration to ensure accurate imaging performance and compliance with regulatory standards for X-ray equipment.
How is this device regulated, and what does its classification mean for users?
This system is authorized under FDA 510(k) clearance (K840191) and classified as Class II, meaning it is subject to general controls and special controls to ensure safety and effectiveness. The classification does not imply a higher risk but requires adherence to specific regulatory requirements, including compliance with 21 CFR 892.1650.
Are there multiple models or sizes available for this system, and how would I identify them?
The system is listed with multiple FEI numbers (e.g., 3013099020, 3005706667), which likely correspond to different models or configurations. These identifiers are used in regulatory filings and may help distinguish variations in the system’s specifications or capabilities. For precise details, refer to the manufacturer’s documentation or contact Adac Laboratories.
Does this device have any special handling requirements, such as sterility or storage conditions?
The data does not specify any sterility requirements or single-use designation for this system, as it is designed for reusable use in radiology departments. Proper storage conditions should focus on protecting the equipment from physical damage and environmental factors that could affect its performance, such as extreme temperatures or humidity.